<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200301046657N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-29</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effects of functional electrical stimulation in multiple sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effects of functional electrical stimulation with and without ankle foot orthosis on balance and walking ability in multiple sclerosis using BESTest</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46640</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients involved with multiple sclerosis with drop foot.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: To help clear the foot we stimulate the peroneal nerve involved in MS disease by electrical stimulation system. This nerve is essential for producing dorsiflexion during the swing phase. The peroneal nerve can also initiate reflex synergistic-based flexion, thereby enhancing hip and knee flexion during the swing gate phase. An electrical stimulation system is a system that uses short pulses and electrical bursts to generate muscle contraction. If these electrical pulses are applied to the motor nerves, it can cause action potentials that extend along the axon to the target muscle, and when this action potential reaches the target muscle, the muscle contracts. Intervention 2: Intervention group: Patients with MS with ankle sprains use orthoses such as the foot-orthosis (AFO), which is used to prevent patients from colliding with the ground during the swinging walk. The orthosis is made of hard plastic and extends from the joint between the bones of the foot and toes to the top of the leg. Ankle-foot orthosis alone is used for people with good leg muscles to move in an upright position. When the patient has dorsiflexion, the orthosis prevents the fingers from touching the ground. If the patient has sufficient knee strength, an adjustable wrist joint may be used in the orthosis, which allows for dorsiflexion and enhances the ease of functional activity.Acceptance of ankle-foot orthosis in these patients is very poor. Weight, appearance or lack of response to patients' needs are the reasons for not using this orthosis.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data can be shared after unidentifiable people

When:
Starting one year after article publication

To whom:
Information is available to all researchers working in academic and scientific institutions

Conditions:
Use of data is only possible by mentioning the name and organizational affiliation of the correspond and co-author of the project and the published article

Where to obtain:
connect to Dr Alireza Khaghani by email: Khaghaniali@yahoo.com

How to obtain:
If information is used ib scintific and therapeutic activities, information is provided as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>علیرضا خاقانی</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation Sciences., Maddekaran St., Shah Nazari St., Mirdamad, Mother Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13487-  15459</zip>
        <telephone>22222059</telephone>
        <email>khaghani.a@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Khaghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation Sciences., Maddekaran St., Shah Nazari St., Mirdamad, Mother Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13478 -15495</zip>
        <telephone>22227124</telephone>
        <email>khaghani.a@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People with MS scores below five on the EDSS index
Patients with multiple sclerosis who have drop foot at least three months
People with walking ability without use of assistive devices
Ability to walk and stand for at least three minutes
Experience using ankle-foot orthoses or functional electrical stimulation, or both
Patient satisfaction to participate in the study
Ability to read and write in Farsi</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of surgery and fractures in the lower extremities
History of lower extremity trauma
Inappropriate postures such as kyphosis and scoliosis
Infection and inflammation of the skin in the calf region
The progression of MS is so debilitating for the individual
Dryness and immobility of the ankle joint
Contraction in the calf muscles
Short back muscles and tendons in the calf
Severe lower limb muscle spasms that affect ankle joint movements
Any abnormalities and deformities in the joints and bones of the foot and ankle
People who need help moving from others or using assistive devices</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: To help clear the foot we stimulate the peroneal nerve involved in MS disease by electrical stimulation system. This nerve is essential for producing dorsiflexion during the swing phase. The peroneal nerve can also initiate reflex synergistic-based flexion, thereby enhancing hip and knee flexion during the swing gate phase. An electrical stimulation system is a system that uses short pulses and electrical bursts to generate muscle contraction. If these electrical pulses are applied to the motor nerves, it can cause action potentials that extend along the axon to the target muscle, and when this action potential reaches the target muscle, the muscle contracts</i_keyword>
      <i_keyword>Intervention group: Patients with MS with ankle sprains use orthoses such as the foot-orthosis (AFO), which is used to prevent patients from colliding with the ground during the swinging walk. The orthosis is made of hard plastic and extends from the joint between the bones of the foot and toes to the top of the leg. Ankle-foot orthosis alone is used for people with good leg muscles to move in an upright position. When the patient has dorsiflexion, the orthosis prevents the fingers from touching the ground. If the patient has sufficient knee strength, an adjustable wrist joint may be used in the orthosis, which allows for dorsiflexion and enhances the ease of functional activity.Acceptance of ankle-foot orthosis in these patients is very poor. Weight, appearance or lack of response to patients' needs are the reasons for not using this orthosis.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The effect of functional electrical stimulation on balance in patients with MS with ankle deprivation. Timepoint: Immediate examination before and after wearing orthoses. Method of measurement: Using tests of BESTest.</prim_outcome>
      <prim_outcome>The effect of using ankle-foot orthosis equipped with functional electrical stimulation on balance in patients with MS. Timepoint: Immediate examination before and after wearing orthoses. Method of measurement: Using tests of BESTest.</prim_outcome>
      <prim_outcome>The effect of functional electrical stimulation on walking ability in patients with MS. Timepoint: Immediate examination before and after wearing orthoses. Method of measurement: Using tests of BESTest.</prim_outcome>
      <prim_outcome>The effect of using ankle-foot orthoses equipped with functional electrical stimulation on walking ability in people with MS. Timepoint: Immediate examination before and after wearing orthoses. Method of measurement: Using tests of BESTest.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-14</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Hemat Highway next to Milad Tower, Iran University of Medical sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
